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19 June 2008 | By
Over the last decade, interest in rapid microbiological methods (RMMs) in the pharmaceutical sector has grown considerably. Technologies such as ATP bioluminescence, solid phase laser cytometry and genetic-based identification systems are being vigorously investigated. Validation and regulatory requirements for such new technologies are beginning to emerge. However, there is a…
23 January 2008 | By Stewart Green Director of Quality, Wyeth, UK and Chair, Pharmig
Arguably microbiology is the oldest of the applied sciences, although early exponents doubtless had no understanding of how the fruits of their labour in fermentation for example, came about. The true forerunners of microbiology as it is recognised today would be Koch, Pasteur, Petri et al, who developed much of…
23 November 2007 | By
In order to meet the challenges demanded by the requirements of Process Analytical Technology (PAT), the modern microbiological laboratory needs to become more innovative in microbial detection, identification and enumeration. Technology is becoming available that will speed up microbiological analysis, potentially allowing pharmaceutical microbiology tests to get as close as…
25 January 2007 | By Dr Andrew M. Middleton, GlaxoSmithKline
Subsequent to the publication of the PDA technical Report Number 33 in 20001 there has been a multitude of articles published in pharmaceutical reviews and commentaries with regard to rapid microbial methods (RMM). The majority of these articles cover, to a greater or lesser degree, the technologies available and summaries…
28 September 2006 | By Tony Cundell, Director, Pharmaceutical Sciences – Microbiology, Schering Plough Research Institute
Following on from our latest report in Issue 4 in which we outlined independent views on ‘solutions for the next stage’ in Rapid Microbiological Methods (RMM) from some of the industry’s leading names, Tony Cundell follows up with his own thoughts on this exciting field.
20 July 2006 | By Tim Lloyd, Editor, European Pharmaceutical Review
Rapid microbiology is an exciting field for the development of new technologies and applications. There are significant challenges to be overcome and in doing so, great prospects for microbiologists and the companies that provide cutting-edge equipment.
2 February 2006 | By Anthony M. Cundell, Ph.D. Consulting Microbiologist
Since the 2000 publication of the PDA Technical Report Number 33 Testing Methods, rapid microbial methods (RMM) have not lived up to their promise for changing routine Quality Control microbiological testing in the pharmaceutical industry. With the next generation of rapid microbial methods emerging from the R&D laboratories of instrument…
11 November 2005 | By Amy McDaniel, Ph.D., QC Manager, Microbial Science & Technology, Wyeth Biotech
Timely results for microbial bioburden monitoring of in-process cell culture samples are critical to the production process for recombinant proteins and other biopharmaceutical products.
20 May 2005 | By Paul J Newby PhD, GlaxoSmithKline R&D
In the last decade interest in Rapid Microbiological Methods (RMMs) has grown considerably. Technologies such as ATP bioluminescence, solid phase laser cytometry and genetic-based identification systems are being vigorously investigated. Validation and regulatory requirements for such new technologies are beginning to emerge. However, there is a lot of confusion and…
